MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-30 for ASTRON CLEAR SPLINT LOWER manufactured by Prismatik Dentalcraft, Inc..
[177014693]
The patients weight is not provided as it is not taken at the time of the appointment.
Patient Sequence No: 1, Text Type: N, H10
[177014714]
It was reported that the patient had a possible allergic reaction. The local noted is "intra-oral. " the patient was reported to have "bumps developing in the mouth around tongue and cheeks where night guard came into contact. " the patient started feeling "weird" on the first day of use, which he believes was (b)(6) 2019. His tongue began to itch, but he wore it for a few nights (3-4 nights). He then discontinued use of the device. " he did not seek medical intervention. He further explains that his nose was increasingly stuffy. The patient returned on (b)(6) 2019 for new impressions and a re-make using different material. The patient was allergy tested. He has no known allergies, except for pollen and dust.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2020-00444 |
| MDR Report Key | 9646774 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2019-10-23 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2019-10-18 |
| Date Added to Maude | 2020-01-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. HERBERT SCHOENHOEFER |
| Manufacturer Street | 2212 DUPONT DRIVE SUITE P |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal | 92612 |
| Manufacturer Phone | 9494402632 |
| Manufacturer G1 | PRISMATIK DENTALCRAFT, INC. |
| Manufacturer Street | 2212 DUPONT DR SUITE P |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92612 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASTRON CLEAR SPLINT LOWER |
| Generic Name | ASTRON CLEAR SPLINT |
| Product Code | MQC |
| Date Received | 2020-01-30 |
| Lot Number | 1105335385 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRISMATIK DENTALCRAFT, INC. |
| Manufacturer Address | 2212 DUPONT DRIVE SUITE P IRVINE CA 92612 US 92612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-30 |